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Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced)

NCT01051076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-08-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on this study is expected to last up to 33 months.

Conditions

  • Severe Hemophilia A

Interventions

DRUG

VWF/FVIII concentrates

200 IU/Kg by one or two bolus injections daily. After successful confirmation the dose will be tailed off progressively until discontinuation. Patients will be treated with a VWF/FVIII concentrates according to physician/patients preference.

Sponsors & Collaborators

  • Charta Foundation

    collaborator OTHER

  • Grifols Biologicals, LLC

    collaborator INDUSTRY

  • CSL Behring

    collaborator INDUSTRY

  • Biotest Pharmaceuticals Corporation

    collaborator INDUSTRY

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Nadia P. Ewing, MD · Clinical Professor of Pediatrics, City of Hope National Medical Center, Dept. of Pediatrics, 1500 E. Duarte Rd. Duarte, CA 91010

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-03
Primary Completion
2020-10-21
Completion
2020-10-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051076 on ClinicalTrials.gov